FentaNYL as citrate 5 mcg/mL in 0 recalled over sterility concerns

Recall date

July 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SCA Pharmaceuticals recalls fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Kno…

Recall number

D-1010-2017

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; product has the potential to leak.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24